New substances are those not listed in the European Inventory of Existing Commercial Substances (EINECS), i.e. those placed on the market for the first time after 18 September 1981.
New substances that are placed on the market in Switzerland (including those imported for professional or commercial purposes) are subject to notification requirements under Chemicals Ordinance.
- The notifier (manufacturer, importer or only representative) must have his habitual residence, registered office or subsidiary in Switzerland.
- New substances which have already been registered in the EU are nonetheless subject to the requirement for notification in Switzerland.
- New substances are also subject to self-regulation requirements under Article 5 of the ChemO.
- The obligation to notify is generally applicable for quantities of more than 1 ton per manufacturer or importer (Swiss quantity).
Substances, which must be notified, do not have to be additionally reported to the product register (RPC). Manufacturers of new substances that are exempt from notification according to article 26, ChemO, must report these within 3 months after first placing them on the market and independently of the obligation to establish a SDS (art. 48, art. 19 ChemO):
a. dangerous substances
b. substances assessed as PBT or vPvB;
c. substances in annex 3 ChemO (candidate list)
d. nanomaterials purposefully containing fibres or tubes with a length of more than 5 μm. Materials with a water solubility of less than 100 mg per liter or with a half-life of 40 days or more in the lungs are considered being biopersistent.
Exemptions to the obligation to report are listed in Article 54 ChemO.
The notification authority for chemicals must be informed of substances which do not have to be notified (art. 26 par. 1 let. e ChemO) and which are intended solely for product and process-orientated research and development (PPORD, art. 34 ChemO).
Last modification 28.11.2018